The Context of Gambling Treatment: Towards Creating an Online Service to Reduce Problem Gambling - Part Five

March 3, 2023 updated by: Centre for Addiction and Mental Health
This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. We will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Disordered gambling is now recognized as a behavioral addiction. Although the physical consequences of the disorder are very mild, the financial and emotional costs can be enormous. This application involves a multi-stage study with the ultimate goal of developing an online treatment service for problem gamblers. This project was originally designed to take place over a three-year period but has been condensed into two. Part one was scoping review. Part two involved focus groups with service providers and people experiencing gambling problems. Part three will gather some general population information on two on going population survey's run by our research team. Part four Involved key informant interviews, and part five would be the development and evaluation of a pilot online treatment service. This application deals with part five of the overall project, Parts two and four were conducted as 025-2017. In this study, we will recruit up to 100 problem gamblers, and offer problem gambling treatment services to them entirely over the internet. The program will be evaluated based on uptake, experience of the participants, and pre-test vs post-test differences in gambling and well-being. The data reported here are related to part 5 only. Due to funding cuts, we were only able to include 2 people in the completed study.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
16

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5S 2S1
        • Centre for Addiction and Mental Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • problem gamblers seeking treatment who are 18 years and older must be willing to have therapy conducted online must have access to a computer and Internet be able to communicate in English.

Exclusion Criteria:

  • not able to communicate in English, has current suicidal ideation, acute psychotic symptoms, current involvement in other gambling treatment, has severe substance abuse problem or complex mental health problems (as assessed by screening tools)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Online treatment
The participants will receive counseling over the internet.
Other: Online therapy
Standard counseling provided over the internet.
No Intervention: Non-treatment
Participants who did not participant in the group were asked to complete the 12ve month followup questionnaire (but not the post treatment questionnaire).

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling.
Time Frame: Change from baseline to 3 months
Level of gambling frequency was measured using self reported frequency on a 7 point scale on 12 types of gambling. We used the maximum frequency across the twelve types of gambling so that if they reported participating in 5 types of gambling ranging from once per year (score of 1) to everyday (score of 7), we would score the person as 7. This way the measure was sensitive to changes in the most problematic frequent form of gambling for that person. Lower levels of gambling frequency after 12 months would be a positive outcome. To score frequency we computed each person's highest frequency for a range from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling. The same was done for their post-test scores. We computed the difference score of post-test from pre-test which could range from 7 to -7 with negative numbers indicating improvement (reduced gambling participation).
Change from baseline to 3 months
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Time Frame: Change from baseline to 3 months
Gambling problems are measured using PGSI (Ferris & Wynne, 2001). Each of the 9 item is measured on a 4 point scale from never (0) to almost always (3). The total ranges from 0 to 27. Higher scores indicate more gambling problems; Lower scores at followup would be a positive outcome. Total scores form 3 to 7 indicate moderate gambling problems; scores 7 or higher indicate severe gambling problems. In this study we subtracted pre-test scores from post test scores to compute a change score which would range from27 to -27 with higher number indicating a worse outcome and negative numbers indicating a positive outcome.
Change from baseline to 3 months
Changes in Kessler-6 (K6; Galea, et al., 2007).
Time Frame: Change from baseline to 3 months
The Kessler-6 measures psychological distress (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). For the evaluation we computed the difference of post-test from pre-test with a range from 25 to -25 with negative numbers indicating an improvement.
Change from baseline to 3 months
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Time Frame: Change from baseline to 3 months
Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003). Range 1 to 6 based on average score per item; higher scores mean greater mindfulness. For the evaluation we computed the difference of the post-test and the pre-test for a range from 6 to -6 with positive numbers indicating an improvement in mindfulness.
Change from baseline to 3 months
Changes in Number of Games Played
Time Frame: Change from baseline to 3 months
Number of games played was measured using a self report measure of participation in 12 games (see frequently above). Fewer games played would be a positive outcome. Possible range is from 0 to 12. We computed the difference score from pre-test to post-test which could range from 12 to -12 with negative numbers indicating improvement (reduced gambling participation).
Change from baseline to 3 months

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Gambling Frequency as Measured by Self Reported Frequency on 12 Different Types of Gambling
Time Frame: Change from baseline to 12 months followup
Level of gambling frequency was measured using self reported frequency on a 7 point scale on 12 types of gambling. We used the maximum frequency across the twelve types of gambling so that if they reported participating in 5 types of gambling ranging from once per year (score of 1) to everyday (score of 7), we would score the person as 7. This way the measure was sensitive to changes in the most problematic frequent form of gambling for that person. Lower levels of gambling frequency after 12 months would be a positive outcome. To score frequency we computed each person's highest frequency for a range from 0 (none) to 7 (everyday) with higher numbers indicating more frequent gambling. The same was done for their post-test scores. We computed the difference score of post-test from pre-test which could range from 7 to -7 with negative numbers indicating improvement (reduced gambling participation).
Change from baseline to 12 months followup
Changes in Problem Gambling Severity Index (PGSI; Ferris & Wynne, 2001).
Time Frame: Change from baseline to 12 months followup
Gambling problems are measured using PGSI (Ferris & Wynne, 2001). Each of the 9 item is measured on a 4 point scale from never (0) to almost always (3). The total ranges from 0 to 27. Higher scores indicate more gambling problems; Lower scores at followup would be a positive outcome. Total scores form 3 to 7 indicate moderate gambling problems; scores 7 or higher indicate severe gambling problems. In this study we subtracted pre-test scores from post test scores to compute a change score which would range from27 to -27 with higher number indicating a worse outcome and negative numbers indicating a positive outcome.
Change from baseline to 12 months followup
Changes in Kessler-6 (K6; Galea, et al., 2007).
Time Frame: Change from baseline to 12 months followup
The Kessler-6 measures psychological distress (K6; Galea, et al., 2007). Higher scores indicate more psychological distress. Score 0 to 25 with scores over 8 indicating moderate psychological distress. We are predicting lower levels of psychological distress at 3 follow-up as measured using the Kessler-6 (K6; Galea, et al., 2007). For the evaluation we computed the difference of post-test from pre-test with a range from 25 to -25 with negative numbers indicating an improvement.
Change from baseline to 12 months followup
Changes in Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003).
Time Frame: Change from baseline to 12 months followup
Mindfulness was measured using the Mindful Attention Awareness Scale (MAAS; Brown & Ryan, 2003). Range 1 to 6 based on average score per item; higher scores mean greater mindfulness. For the evaluation we computed the difference of the post-test and the pre-test for a range from 6 to -6 with positive numbers indicating an improvement in mindfulness.
Change from baseline to 12 months followup
Changes in Number of Games Played
Time Frame: Change from baseline to 12 months followup
Number of games played was measured using a self report measure of participation in 12 games (see frequently above). Fewer games played would be a positive outcome. Possible range is from 0 to 12. We computed the difference score from pre-test to post-test which could range from 12 to -12 with negative numbers indicating improvement (reduced gambling participation).
Change from baseline to 12 months followup

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Time Frame: Change from baseline to 3 months
Higher levels of quality of life is expected as a result of the intervention. Each item was scored on a 6 point scale from "1, At no time" to "6, All of the time" for a total score ranging from 6 to 30. To assess the outcome we computed the difference score from pre-test to post-test which could range from 24 to -24 with positive numbers indicating improvement (higher quality of life).
Change from baseline to 3 months
Changes in Quality of lifeInventory (QLI) (Heun, et al., 2001)
Time Frame: Change from baseline to 12 months followup
Higher levels of quality of life is expected as a result of the intervention. Each item was scored on a 6 point scale from "1, At no time" to "6, All of the time" for a total score ranging from 6 to 30. To assess the outcome we computed the difference score from pre-test to post-test which could range from 24 to -24 with positive numbers indicating improvement (higher quality of life).
Change from baseline to 12 months followup
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Time Frame: Change from baseline to 3 months
This scale measures perception of social support. Each item is measured on a 7 point scale from 1 to 7, for a total score of 12 to 84. Higher scores indicate higher levels of social support, so an increase in social support would be a positive change. For the evaluation we computer the differences from pre-test to post-test for a range from 72 to -72 with positive numbers indicate an improvement in perceived social support.
Change from baseline to 3 months
Changes in Perceived Social Support (PSS) (Zimet et al., 1988)
Time Frame: Change from baseline to 12 months followup
This scale measures perception of social support. Each item is measured on a 7 point scale from 1 to 7, for a total score of 12 to 84. Higher scores indicate higher levels of social support, so an increase in social support would be a positive change. For the evaluation we computer the differences from pre-test to post-test for a range from 72 to -72 with positive numbers indicate an improvement in perceived social support.
Change from baseline to 12 months followup
Changes in The Random Events Knowledge Test (REKT)
Time Frame: Change from baseline to 3 months
This scale measures the participants understanding of random events using a true or false format.. Each item is scored as correct or incorrect for a total score of 0 to 28. Higher scores mean they have a better understanding of random events and an increase in score would be a positive change. For the evaluation we computed the difference from pre-test to post-test for a range from 28 to -28 with positive number indicating improvement in the participants understanding of random chance.
Change from baseline to 3 months
Changes in The Random Events Knowledge Test (REKT) Turner et al., (2006)
Time Frame: Change from baseline to 12 months followup
This scale measures the participants understanding of random events using a true or false format.. Each item is scored as correct or incorrect for a total score of 0 to 28. Higher scores mean they have a better understanding of random events and an increase in score would be a positive change. For the evaluation we computed the difference from pre-test to post-test for a range from 28 to -28 with positive number indicating improvement in the participants understanding of random chance.
Change from baseline to 12 months followup
Changes in Visual Analog Scale of Cravings.
Time Frame: Change from baseline to 3 months
The visual analog scale is based on similar measures used in drug research (e.g., Duncan, et al., 2001; Berger, et al., 1996). Each of 4 items is scored from 0 to 100, and the average is computed for a range from 0 to 100 with higher scores mean more cravings to gamble. A positive outcome would be lower scores at followup. For the evaluation we computed the difference between the post-test and pre-test for a range from 100 to -100, with negative numbers indicating an decrease in cravings.
Change from baseline to 3 months
Changes in Visual Analog Scale of Cravings.
Time Frame: Change from baseline to 12 months followup.
The visual analog scale is based on similar measures used in drug research (e.g., Duncan, et al., 2001; Berger, et al., 1996). Each of 4 items is scored from 0 to 100, and the average is computed for a range from 0 to 100 with higher scores mean more cravings to gamble. A positive outcome would be lower scores at followup. For the evaluation we computed the difference between the post-test and pre-test for a range from 100 to -100, with negative numbers indicating an decrease in cravings.
Change from baseline to 12 months followup.
Changes in Total Money Spent
Time Frame: Change from baseline to 3 months
Self report measure of money spent gambling in past 6 months. Lower amounts spend would be a positive outcome.For the evaluation we compute the difference between spending at post-test from pre-test with negative numbers indicating an improvement (decrease in spending).
Change from baseline to 3 months
Changes in Total Money Spent
Time Frame: Change from baseline to 12 months followup.
Self report measure of money spent gambling in past 6 months. Lower amounts spend would be a positive outcome.For the evaluation we compute the difference between spending at post-test from pre-test with negative numbers indicating an improvement (decrease in spending).
Change from baseline to 12 months followup.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Centre for Addiction and Mental Health

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Ministry of Health and Long Term Care

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Nigel E Turner, Ph.D, Centre for Addiction and Mental Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2019

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 9, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 14, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 6, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 20, 2021

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
March 7, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 3, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 074-2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

Individual data will not be shared with other researchers.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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Sponsors and Collaborators

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Drug Interventions

Conditions

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Dietary Supplements

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Locations

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